NCT03857269

Brief Summary

This study aims to investigate and compare the intervention effects of acupressure,aromatherapy,combining acupressure and aromatherapy in elderly with mild cognitive impairment. The investigators hypothesize that (1) Combined intervention can induce greater improvements in the outcome measures than single mode of intervention; (2) the improvement in cognitive functions and other outcomes may differ between the groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

February 23, 2019

Last Update Submit

August 23, 2019

Conditions

Mild Cognitive Impairment

Keywords

acupressureAromatherapyNursing Homeschina

Outcome Measures

Primary Outcomes (2)

  • Mini-mental State Examination

    The table is simple and easy to use, widely used at home and abroad, and is the preferred scale for dementia screening. The scale includes the following seven aspects: time-orientation, location-orientation, immediate memory, attention and computational power, delayed memory, language, and visual space.The total score of the scale ranges from 0-30 points. The test scores are closely related to the cultural level. The normal boundary value is:uneducated people（\>17）.primary school education（\>20）, and middle high school or above（\>24）, indicating good mental state. The higher the total score, the better the situation.

    Change from baseline in Mini-mental State Examination at month 3 and month 6. To investigate the Intelligence state.

  • Wechsler Intelligence Scale

    There are ten aspects of the scale. Consult relevant experts and consult literature, this program selects four aspects: logical memory(0\~25), association learning(0\~21), picture recall(0\~20), and number of memories(0\~17).Add the total scores, the higher the score, the better the memory.

    Change from baseline in Wechsler Intelligence Scale at month 3 and month 6. To investigate the Memory capacity.

Secondary Outcomes (2)

  • Geriatric depression scale

    Change from baseline in Geriatric depression scale at month 3 and month 6. To investigate the Functional Activities status.

  • Pittsburgh sleep quality index

    Change from baseline in Pittsburgh sleep quality index at month 3 and month 6. To investigate the Functional Activities status.

Study Arms (4)

Acupoint Massage group

EXPERIMENTAL

Choose Chinese medicine acupuncture points： Shenting, Baihui, Sishencong, Diwei, Chengling, Fengchi, Fengfu，Zusanli and Sanyinjiao，32 points per acupressure.32 times per acupoint.Intervention frequency will be monday to saturday per week for 6 months.（n=30）

Other: Acupoint Massage

Aromatherapy group

EXPERIMENTAL

Make a 5x5cm bag and put a cotton ball in the bag and the bag is clipped to the patient's collar.Dispense 10% lavender essential oil, 2-3 drops a day in cotton balls.Cotton ball replacement daily. Intervention frequency will be monday to saturday per week for 6 months.（n=30）

Other: lavender essential oil

Acupoint Massage and Aromatherapy group

EXPERIMENTAL

At the same time as the acupressure, the essential oil is applied to the collar and begins to sniff.Intervention frequency will be monday to saturday per week for 6 months.（n=30）

Other: Acupoint Massage and lavender essential oil

Blank control group

NO INTERVENTION

The group selects elderly people with MCI who do not receive intervention after informed.Participate in routine activities of Nursing homes.

Interventions

Acupoint MassageOTHER

The operators is trained for two weeks. At 9 o'clock in the morning, the elderly are organized by Nursing home to perform acupressure.Intervention frequency will be monday to saturday per week for 6 months.

Also known as: AM
Acupoint Massage group
lavender essential oilOTHER

Modulated by an international aroma therapist,The cotton ball containing essential oil is replaced by the operator at 9 am.Intervention frequency will be monday to saturday per week for 6 months.

Also known as: EO
Aromatherapy group
Acupoint Massage and lavender essential oilOTHER

At the same time as the acupressure, patients began to smell the essential oil.Intervention frequency will be monday to saturday per week for 6 months.

Also known as: AM&EO
Acupoint Massage and Aromatherapy group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese people aged 60 years or above;
  • the MOCA screening score \<26, which was corrected based on educational level (Education time \<12, plus one point)
  • ability to perform self-care functions on their own;
  • no confirmed diagnosis of dementia, depression or other psychiatric illnesses which would interfere with cognitive performance;
  • capacity to provide informed consent.

You may not qualify if:

  • had a medical history of chronic alcoholism or brain trauma occurred in previous years that could interfere with cognition;
  • had been regular users of medications that could affect cognition;
  • had clinical conditions that contraindicated light to moderate physical exercise；
  • any disabilities preventing participation in the MET or KY conditions (e.g. severe visual or hearing impairment);
  • people with olfactory dysfunction or those who are allergic to lavender；
  • skin is broken, can not be massaged；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing University of Chinese Medicine

Nanjing, Jiangsu, 210046, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Huan Ding

    School of Nursing, Nanjing University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
School of Nursing, Nanjing University of Traditional Chinese Medicine

Study Record Dates

First Submitted

February 23, 2019

First Posted

February 27, 2019

Study Start

December 27, 2018

Primary Completion

September 30, 2019

Study Completion

October 30, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

CN(1)